2021 was a fascinating year in biotech, especially for legal issues. Of course, 2021, as the second year of a global pandemic, must be viewed in context with 2020.
The obvious "big story" is the roll out of quickly available vaccines, their differing efficacies in dealing with a mutating virus, and many special "treatments" that these viruses received in the approval process and in the many cases of virtual exemption from product liability suits. There are four different types of these vaccines throughout the world - inactivated, live-attenuated, viral vector, and subunit (like mRNA) approach. The mRNA seemed to have the best effect initially, but it also waned pretty quickly over time. No one approach has proven the best against the many mutants.
The abbreviated approval process for these vaccines almost certainly will motivate improvement in the process and speed of drug approval in these governmental agencies (such as FDA and EMA).
Mergers & Acquisitions
M&A for biotech exploded in 2021, both acquisitions of startups and funding for new companies. We do not know the details about all these deals, but we expect some unique terms that may move the standard for biotech M&A and investment. COVID-19 also brought biotech to the forefront in 2021, and that supported a substantial amount of deals (and money) flow.
Both genetics and ownership of your own genetics were large issues this year. Vendors of DNA/ancestry testing also began to provide beneficial health information. Law enforcement developed a strategy for looking for genetic near-matches to reduce (or often confirm) possible suspects of crimes. Often, bodily fluids are available at a crime scene, but no matches turn up in official databases. So, they learned how to turn to unofficial databases, ones where customers voluntarily submitted DNA to learn more about ancestors and relatives, as well as health information. This became fertile ground for law enforcement, especially if they had a suspect and needed more to warrant DNA testing. This seems to many to be overreach, in terms of personal information of relatives who are not
suspects. Standards likely will develop to limit this. Also, many of these DNA/ancestry companies may be motivated to stave off these law enforcement "requests" more forcibly. Some surrendered data with little resistance.
Henrietta Lacks Case
Finally, as alluded to above, the new Henrietta Lacks case brings up the issue of who owns a person's tissues and genetic material. A more detailed article on that can be found here
. It amazes me that in 2021 we still are struggling with the question of whether a human, who clearly owns his/her own writings, voice, image, etc., also owns his/her own tissue, even after death.
You may have your own list, but this is what fascinated me this year. Happy Christmas to all, and have a safe and prosperous New Year!